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FDA 510(k)

BIOTEL MICROALBUMINURIA (TM)

K-Number: K894169 · 1989-09-18

ApplicantAmerican Diagnostic Corp.
Decision Date1989-09-18
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTEL MICROALBUMINURIA (TM) is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1989-09-18 under 510(k) number K894169. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEL MICROALBUMINURIA (TM)?

BIOTEL MICROALBUMINURIA (TM) is a medical device that received FDA 510(k) clearance on 1989-09-18. The listed applicant is American Diagnostic Corp.. The 510(k) number is K894169.

When did BIOTEL MICROALBUMINURIA (TM) receive FDA 510(k) clearance?

BIOTEL MICROALBUMINURIA (TM) received FDA 510(k) clearance on 1989-09-18, under 510(k) number K894169.

Who is the listed applicant for BIOTEL MICROALBUMINURIA (TM)?

The FDA 510(k) record lists American Diagnostic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOTEL MICROALBUMINURIA (TM)?

The FDA product code for BIOTEL MICROALBUMINURIA (TM) is JIR.

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Other records listing American Diagnostic Corp. as applicant

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Related Devices (Code: JIR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222921Minuteful-kidney testHealthy.Io, Ltd.K210069Minuteful - kidney testHealthy.Io, Ltd.K061419TECO MICROALBUMIN 2-1 COMBO STRIPSTeco DiagnosticsK022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25Diagnostic Chemicals, Ltd. (Usa)K001810URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTINGFlexsite Diagnostics, Inc.K994035IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15Diagnostic Chemicals , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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